The Effect of Mechanical Vibration and Flick Tapping Methods in Reducing Pain in Infant Vaccination

NCT07185152 | Completed DMC

• 2 other identifiers: E-95674917-108.99-245388TDK-2024-15853
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A research protocol examining the effect of vibration on the crying duration variable in needle-related medical procedures in newborns also predicted that vibration therapy would be effective in reducing pain caused by vaccine injection and shortening the newborn's crying time. Flicking the injection site can be used to control pain in childhood. To date, only one experimental study testing the flick method has reported that the flick method applied before intramuscular injection had lower pain scores in babies during and after vaccination. Studies show that the positive effects of both methods are mentioned. However, no study has been found to examine the effects of both methods on injection pain that may occur when the second dose of Hepatitis B vaccine is administered in the neonatal period and compare their effects. The fact that the effects of mechanical vibration and flicking methods as pain relief strategies on reducing pain, physiological parameters and crying duration have not been examined in this population before shows the deficiency in the literature.This study aimed to examine the effect of flicking the injection site before the second dose of the Hepatitis B vaccine applied to the anterior surface of the vastus lateralis muscle in infancy and applying mechanical vibration to the injection site throughout the vaccination procedure on acute pain, crying duration and physiological parameters that may occur due to intramuscular injection.

Conditions

Health Knowledge, Attitudes, Practice; Health Behavior

Keywords

Infant, Pain, Pediatric nursing, Vaccines, Vibration

Outcome Measures

Primary Outcomes (6)

• Newborn infant pain assessment

  Before, during, and after the procedure, infants' behavioral responses to pain were recorded using NIPS.

  The behavioral states of the infants were recorded with NIPS one minute before the procedure. The infants' responses to the pain they felt during the procedure were recorded with NIPS during the procedure. The infants' behavioral responses to pain after

• body temperature measurement

  Body temperature was measured before and after the procedure.

  Body temperature was measured one minute before the procedure. Body temperature was measured one minute after the procedure.

• respiratory rate measurement

  The infants' respiratory rate was measured before and after the procedure.

  Respiratory rate was measured for 1 minute before the procedure began. Respiratory rate was measured until the first minute after the procedure.

• Oxygen saturation measured

  Oxygen saturation was measured before, during, and after the procedure.

  Oxygen saturation was measured one minute before the procedure, during the procedure, and for one minute after the procedure.

• heart rate measured

  Heart rate was measured before, during, and after the procedure.

  Heart rate was measured one minute before the procedure, during the procedure, and up to the first minute after the procedure.

• Crying duration measurement

  The crying time was measured for one minute after the procedure.

  With the start of the vaccination process, the crying duration was recorded on the Newborn Observation Form for one minute. The start of the procedure and the crying duration were recorded for one minute.

Secondary Outcomes (5)

• Newborn infant pain assessment

  One minute before the procedure, behavioral responses to pain were recorded using NIPS. During the procedure, behavioral responses to pain were recorded using NIPS. Behavioral responses to pain were recorded using NIPS for one minute after the procedure.

• Body temperature measured.

  Body temperature was measured one minute before and one minute after the procedure.

• Respiratory rate measured

  Respiratory rate was measured for 1 minute before the procedure began. Respiratory rate was measured until the first minute after the procedure.

• oxygen saturation measured

  Oxygen saturation was measured one minute before the procedure, during the procedure, and up to the first minute after the procedure.

• Heart rate measured

  Heart rate was measured one minute before the procedure, during the procedure, and for one minute after the procedure.

Study Arms (3)

Mechanical Vibration group

EXPERIMENTAL

Babies randomized to the Mechanical Vibration group were subjected to vibration approximately 1 cm above the injection site with a mechanical vibration device before and during the vaccination procedure.

Other: mechanical vibration

Flick tapping group

EXPERIMENTAL

Before the vaccination procedure, the vaccination site was placed on the nail of the middle finger in the babies randomized to the flick tapping group, and then the vaccination was stimulated with a quick tap using the upper nail part of the middle finger.

Other: Flick tapping

Control groups

NO INTERVENTION

The routine vaccination procedure was administered to the infants in this group.

Interventions

mechanical vibration OTHER

Mechanical vibration was applied to babies randomized to the mechanical vibration group before and during the vaccination procedure.

Mechanical Vibration group

Flick tapping OTHER

Before the vaccination procedure, the vaccination site was placed on the nail of the middle finger in the babies randomized to the flick tapping group, and then the vaccination was stimulated with a quick tap using the upper nail part of the middle finger.

Flick tapping group

Eligibility Criteria

• Age: 30 Days - 42 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mothers agreeing to participate in the study,
• The baby's gestational age being between 38 and 42 weeks,
• Babies being 30-42 days old after birth,
• The baby's birth weight being between 2500 g and 4000 g
• The infant has not been given pain medication prior to vaccination and has a normal body temperature.

You may not qualify if:

• Araştırmaya katılmayı kabul etmeyen anneler,
• Gestasyonel yaşı 38. haftanın altında 42. haftanın üzerinde olan bebekler,
• Konjenital hastalık veya doğumsal anomalisi olan bebekler olarak belirlendi.

Sponsors & Collaborators

• Berrin GOGER: lead

Study Sites (1)

Kelkit No. 1 Family Health Center

Gümüşhane, 29600, Turkey (Türkiye)

Location

Related Links

• Principal investigator Berrin GÖGER's institutional affiliation web address
• Principal investigator Berrin GÖGER's institutional affiliation web address

MeSH Terms

Conditions

Behavior; Health Behavior; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• BERRİN GÖGER, LECTURER

  GU, KSDHSV School, Department of Medical Services and Techniques, Gümüşhane, Türkiye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: There are 3 groups in the randomized controlled experimental study. Mechanical vibration method was applied to one group, flick tapping method was applied to one group, and one group was included in the study as a control group without any intervention.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 22, 2025
• Study Start: April 29, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)